Principal Quantitative Pharmacologist - PMx Strategy Lead

BioSpace

New Jersey

On-site

USD 151,000 - 246,000

Full time

5 days ago

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Job summary

Regeneron is seeking a Principal Quantitative Pharmacologist in Pharmacometrics (PMx) to design and conduct sophisticated PMx analyses, supporting program development strategies across multiple experiments and clinical trials. The role communicates PMx results to development teams and helps shape regulatory interactions with informed, data-driven insights.

The candidate will contribute to PMx documentation for regulatory submissions, mentor staff, and represent PMx at pre-IND and HA meetings

Qualifications

PhD with 5+ years or an MS with relevant industry experience.
Familiarity with exposure-response analysis, translational modelling/pharmacology, NLME, logistic regression, survival analysis, Bayesian approaches, disease modelling/QSP advantageous.

Responsibilities

Designs and conducts quantitative PMx analyses to support program development strategies.
Keeps PMx management informed of significant results.
Communicates robust PMx results to cross-functional teams in accessible language.
Implements PMx changes to program strategy and regulatory interactions.
Authors PMx contributions to regulatory documents (IBs) and briefing documents for pre-IND, EOP2, and HA meetings.
Prepares and delivers study reports and regulatory submission documents.
Contributes tables and figures for senior management presentations.
Drafts and reviews PMx documentation for clarity and accuracy.
Performs additional analyses to support regulatory interactions.
Mentors PMx staff and represents PMx at meetings with some supervision.